Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)

Официальное название

Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients

Обзор

This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.

Подробное описание

Therapeutic drug monitoring (TDM) could serve as a valuable tool to minimize adverse events and maximize the efficacy of treatment in breast cancer patients receiving CDK4/6 inhibitors (ribociclib, abemaciclib, palbociclib). However, current TDM performed via venous blood draws can be inconvenient, especially for repeated sampling.

This study aims to evaluate the reliability of capillary (fingertip) microsampling-which could be performed at home as a less invasive alternative to standard venous sampling for measuring residual drug concentrations.

Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen): 4 capillary samples (using the VAMS Mitra device) including 2 samples collected by the study nurse who will train the patient to perform the 2 following samples him/herself; and 1 venous sample (5 mL heparinized tube).

Вмешательства

• Другое Capillary samples using the VAMS Mitra device
  Five blood samples will be collected at a single time point during treatment, in accordance with the routine TDM schedule (the treatment duration will remain as per the prescribed CDK4/6 regimen). * 4 capillary samples (using the VAMS Mitra device) including 2 samples collected by the study nurse then 2 samples collected by the patient. * 1 venous sample (5 mL heparinized tube).

Первичные конечные точки

• Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling. [Срок оценки: Day 1]

Вторичные конечные точки (2)

• Intra-patient's variability of the measurements from microsamplings [Срок оценки: Day 1]
• Acceptability of the device, as assessed by a patient satisfaction questionnaire. [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Adult patients (≥ 18 years) with breast cancer.
• Patients currently receiving ribociclib, abemaciclib, or palbociclib.
• Patients capable of performing capillary sampling (with or without assistance).
• Patient information and signing of informed consent.
• Patient ability to comply with protocol requirements.
• Patients covered by a health insurance system.

Критерии исключения

• Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.
• Persons deprived of their liberty or under guardianship.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• Institut Curie Paris — Paris
• Institut Curie — Saint-Cloud

Идентификаторы

NCT: NCT07491380 · IC 2025-03 · ID RCB: 2025-A01797-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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